A Pilot Study of (MR) Imaging With Pyruvate (13C) to Detect High Grade Prostate Cancer (pyruvate)
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|ClinicalTrials.gov Identifier: NCT02526368|
Recruitment Status : Recruiting
First Posted : August 18, 2015
Last Update Posted : February 20, 2020
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Drug: Pyruvate (13C)||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study of Magnetic Resonance (MR) Imaging With Hyperpolarized Pyruvate (13C) to Detect High Grade Localized Prostate Cancer|
|Actual Study Start Date :||March 22, 2016|
|Estimated Primary Completion Date :||December 31, 2020|
|Estimated Study Completion Date :||June 30, 2021|
Experimental: Pre-surgical Prostate Cancer patients
A minimum of 20 patients will be required to have high-risk localized disease as defined by primary Gleason score of 4 or 5 on prior prostate biopsy.
Magnetic Resonance (MR) scan using pyruvate (13C) injection prior to prostate surgery.Participants will remain monitored on the study until the time of your radical prostatectomy or 30 days after the pyruvate (13C) injection, whichever is longer.
Drug: Pyruvate (13C)
Pyruvate injection followed by a magnetic resonance imaging (MRI) scan.
Other Name: Hyperpolarized Pyruvate (13C)
- Difference in peak lactate/pyruvate conversion with histologic grade of prostate cancer [ Time Frame: Baseline, 1 day ]Measuring difference between peak intra-tumoral lac/pyr ratio and HP lactate area under curve (AUC) on HP C-13 MRI with histologic grade (benign, low grade, high grade).
- Frequency of Treatment-Related Adverse Events as measure of safety [ Time Frame: Up to 2 years ]Assessment of the occurrence of clinically significant changes in safety variables from baseline. Safety endpoints include monitoring for the occurrence of treatment-emergent AEs. Toxicities will be graded using the National Cancer Institute (NCI) Common Terminology (Toxicity) Criteria for Adverse Events (CTCAE) version 4.0.
- Optimal cut-off value of lactate/pyruvate that accurately detects primary Gleason 4 component cancer. [ Time Frame: Baseline, 1 day ]
- Correlation of histologic markers with peak intra-tumoral lactate/pyruvate ratio [ Time Frame: Baseline, 1 day ]Correlation between intra-tumoral lac/pyr ratio and lactate AUC with immunohistochemical markers including LDHA, Ki-67, MYC, and MCT1/MCT4 expression
- Comparison of mean intra-tumoral lac/pyr signal and lactate AUC with adverse clinical and pathologic characteristics [ Time Frame: Up to 2 years ]Association between mean intra-tumoral lac/pyr signal and lactate AUC with adverse clinical and pathologic characteristics including extracapsular extension, positive nodal involvement, and failure to achieve undetectable Prostate-specific antigen (PSA) nadir following prostatectomy
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02526368
|Contact: Christopher Sotto, MD||(415) 353-9452||Christopher.Sotto@ucsf.edu|
|Contact: Rahul Aggarwal, MDfirstname.lastname@example.org|
|United States, California|
|University of California, San Francisco||Recruiting|
|San Francisco, California, United States, 94158|
|Contact: Christopher Sotto 415-353-9452 Christopher.Sotto@ucsf.edu|
|Contact 877-827-3222 email@example.com|
|Principal Investigator: Rahul Aggarwal, MD|
|Principal Investigator:||Rahul Aggarwal, MD||University of California, San Francisco|